JP5483203B2 - Coupling device - Google Patents

Description

  The present invention relates to a coupling device, and more particularly to a coupling device that connects each end to connect one tubular member to another.

  The present invention also provides for performing treatments involving extraction of fluid from a living body / infusion of fluid into a living body through a catheter and a hose connected thereto, specifically for living body, particularly human. It relates to the use of said device intended to connect a catheter inserted into the body.

  Certain embodiments are configured by connecting a catheter inserted into a human body to perform an infusion.

  A notable disadvantage of the known device is that the fluid flowing through the two hoses and their connections has been exposed to an open environment before it for a very limited time, even if it is minimal. It is certainly not completely prevented from touching the surface.

  Such contact, when it comes to revealing, can in general be accompanied by contamination of the fluid that would compromise the purity and / or complete sterility of the fluid itself. is there.

  In detail, when one of the tubular members is a catheter, a foreign agent is introduced into the living body due to foreign substances, which may be foreign and pathogenic.

  Another frequent problem is determining the opening of the tubular member that is already inserted into the living body at the very moment when the tubular member is connected to the second hose.

  When a central venous catheter (CVC) is indicated for illustrative purposes, it is filled with heparin to prevent blood clotting when not in use. Heparin does not mix with blood and is maintained in place by blood pressure. In use, the catheter is connected to a second catheter and heparin is first withdrawn. The wash solution is then used and the catheter is used for infusion or drug administration, after which all blood is emptied and refilled with heparin.

  The above steps are at a fairly complex level and require very precise and instantaneous opening and closing of the end of the catheter inserted into the body, such as when heparin is withdrawn or plasma enters. .

  In medical practice, complex work is required to prevent any contamination or contamination of the blood system, which can only be performed by highly skilled medical personnel. When such skilled personnel are in short supply, it is impossible to perform connection work under clinically safe conditions, and medical treatment cannot be performed outside of a substantially hygienic facility.

  The technical problem underlying the present invention is to provide a coupling device that can avoid the above-mentioned drawbacks associated with known techniques.

Such a problem is a coupling device connecting the two ends of each tubular member,
A first case for accommodating a first end of each first tubular member comprising a closing means;
The flexible end portion of each second tubular member is housed therein and moves the second end of the second tubular member from a retracted position to a position engaged with the first end; and A second case comprising means for doing the reverse,
* Means for reversibly connecting the first case and the second case at their respective coupling ports to define a sealed environment;
In order to open and close the first end, the second end engages and disengages and the closing means is automatically mechanically activated and solved by a coupling device that is deactivated.

  The advantage of the device according to the invention is that the flowing fluid receives the end of the part and the tubular member held in a closed case that is packaged and prepared with great care in a special working range. It is only possible to make contact, thus ensuring that any other surface is excluded. The joining operation is inherently easy.

  Furthermore, through the connecting step, the opening and closing of the tubular member takes place simultaneously with the engagement of the ends of the two tubular members in such a way as to prevent any contamination.

  By forming the tubular system without any hemostatic treatment, the risk of blood clotting is avoided.

  The invention will now be disclosed in accordance with some preferred embodiments thereof, given by way of example and not limitation, with reference to the accompanying drawings, in which:

1 is an exploded perspective view of a coupling device according to a first embodiment of the present invention. FIG. FIG. 2 is a perspective view of some details of the coupling device of FIG. 1. FIG. 3 is another perspective view of another detail of the coupling device of FIG. FIG. 2 is a partial cross-sectional perspective view of the device of FIG. 1 in a first working configuration. FIG. 3 is an enlarged cross-sectional view of details of the device of FIG. 1 in a second working configuration. FIG. 5 is a diagram of the device of FIG. 4 with the device in a third working configuration. FIG. 4B is a diagram of the device of FIGS. 4 and 4A with the device in a fourth working configuration. It is sectional drawing of the device in a 5th operation | work structure. It is sectional drawing of the device in a 6th operation | work structure. FIG. 7B is a diagram of the device of FIG. 7A with the device in a seventh working configuration. FIG. 17 shows a part of a more enlarged detail of the device of FIG. 1 in an eighth working configuration.

  Referring to the drawings, the coupling device is generally designated 1. It is intended to connect a set of tubular members at their respective terminal ends.

  In the following, the connected tubular members are understood as flexible catheters of the type used in the clinical field. In this embodiment, the coupling device or connector is used to connect the terminal ends of two catheters, one of which is CVC type, for example for the purpose of infusion. Thus, the general features of the two catheters are, in this embodiment, general features of a catheter suitable for use in a living body.

  Specifically, the first tubular member is composed of a first catheter 2 having a first terminal portion 3 having an enlarged diameter and closed by a first cap 4. Such first end 3 is hereinafter also specified by the term “receiving end”. The purpose of the cap 4 is to fit outside the end 3.

  In this embodiment, the coupling device 1 is intended to connect the first catheter 2 to the second flexible catheter.

  The second catheter thus has a flexible end portion 8 with a respective second end portion 9 connected to the first end portion 3.

  The device 1 includes a first case 5 that receives the first end 3 of the first catheter 2. Such a case 5 has a substantially cylindrical shape and is coaxial with the portion of the catheter 2 that passes through the case in the longitudinal direction.

  The first case 5 includes a distal end 6 in which a port through which the first catheter 2 passes is formed, and a proximal end in which a coupling port arranged at the terminal end 3 of the first catheter 2 is formed. 7.

  The first case 5 has first closing means of the first end 3 indicated generally at 10 and accommodates it. Such closing means can be mechanically actuated by contacting the second end 9 of the second catheter.

  In this embodiment, the closing means includes a tubular pipe 11 that is fitted to the first catheter 12 at each terminal end 3. The pipe 11 is completely accommodated in the first case 5. The pipe 11 has two opposing notches 12 proximate to the terminal end 3, leaving two opposing areas of the catheter 2 exposed.

The closing means is formed on the pipe 11 by means of a locking ring 13 and is fitted with a device 18 in the form of a plier intended to plug into and close the pipe 11 at the distal end 6 of the first case 5. From here, a set of opposing meshing clutches 14 begin, each of which terminates at an actuating end 16 located at the port of the proximal end 7 of the first case 5.

  The lock fixing ring 13 is inserted into the outer surface of the pipe 11 by meshing with a lock seating surface 17 that fits the lock fixing ring 13.

  Each meshing clutch 14 further has teeth 15 that are inserted into the respective notches 12 of the pipe 11. Under normal conditions, the teeth 15 cooperate with each other to compress the terminal end 3 of the catheter 2 and then close it.

  The meshing clutch 14 is formed by an elastic spring plate, and the meshing clutch 14 is bent by applying pressure to each operating end in the longitudinal direction toward the ring 13, that is, toward the distal end 6 of the first case 5. The teeth can be moved away from each other so that the terminal end 3 of the catheter 2 can be opened.

  According to another configuration, the meshing clutch may be of a single type that can cooperate with a stationary stop element, i.e. a tooth, or a recess that houses other teeth.

  One or more clutches are hinged at their ends and reinforced, and can rotate in response to pressure exerted on the working end.

  Such rotation may occur against an elastic force sufficient to keep the catheter closed.

  According to another embodiment, the clutch can be replaced by a deformable pipe that is flattened by elastic means and compresses the catheter by its deformation. Means may be provided for extending the pipe in conjunction with the coupling of the two catheters.

  The device 1 comprises a second case 20 in which the flexible end portion 8 of each second tubular member is accommodated. The second end portion 9 is substantially ring-shaped and is connected to a movable coupling member 21 inside the second case 20.

  The movable coupling member 21 (FIGS. 4 and 4A) includes an end bearing tube 22 with a coupling edge 23 tapered to facilitate insertion of the movable coupling member 21 into the first terminal end 3. An actuating extension 24 having an actuating end 25 which is cup-shaped, outside the end bearing barrel 22 and concentric with it and facing the end 9.

  The actuating end 25 is configured to contact and push against the actuating end 16 of the dog clutch 14 as described in detail below.

  The coupling member 21 may comprise other and / or different means for mechanically deactivating the closing means 10 of the first catheter 2, such as pins or other members.

  The second case 20 has a respective second coupling port, indicated at 26, which is complementary to the coupling port formed at the proximal end 7 of the first case 5.

  In order to implement such coupling, the device 1 comprises means for reversibly coupling the first case 5 and the second case 20 at their respective coupling ports. The coupling means may be a plug-in type or a screw-in type. The work imposed on this means is to define one sealed environment formed by the cases 5, 20, as well as the first end 3 of the first tubular member 2 closed by the cap 4, and the end 3 and the operating end 16 of the meshing clutch 14 of the closing means 10 are arranged at appropriate positions.

The second case 20 is substantially box-shaped and has a flat shape. This has a flat and parallel bottom wall 27 and a front wall 28 , which are connected by a peripheral wall 29 in which a second coupling port 26 is formed.

  The second case 20 engages with the first end 3 of the first tubular member 2 from a position for moving the second end 9 of the second tubular member, that is, the position where the movable coupling member 21 is retracted. It is provided with means for moving it to the position to be moved and vice versa.

  When the second end 9 is engaged and disengaged, the operating edge 25 and the operating end 16 of the closing means 10 come into contact with each other, so that the closing means 10 is automatically mechanically operated, and the first end Part 3 opens and closes.

  In fact, theoretically, the movable coupling member 1 can move quickly with respect to the hinge pin of the second case 20 along or in conjunction with the outer r-radius line.

  The means for moving is indicated generally at 30 and comprises a cam device intended to control the movement of the mobile connecting member, for this purpose the connecting member is indicated generally at 39, It is installed on the movable plate 31 having a plurality of projecting guide pins extending in the vertical direction from the surfaces on both sides toward the movable plate 31.

  The movable plate 31 is substantially parallel to the front wall 28 and the bottom wall 27 and is mounted substantially on the bottom wall 27, and on the opposite side, the knob 33 projects therefrom through a suitable circular hole 34. It is fixed so as not to move by a pivot plate 32 extending from the front wall 28.

  Specifically, the knob 33 protrudes from a circular lift 35 located at the center of the pivot plate to engage the entire area of the circular hole 34 and define an airtight closed space, anyway. The pivot plate 32 can rotate relative to the front wall 28 in response to control by the knob 33.

  The pivot plate 32 has on its opposite surface a rib 36 that substantially forms a first cam shape into which the guide pin 39 of the movable plate 31 facing the pivot plate 32 is inserted.

  Furthermore, from this surface of the pivot plate 32, a cylindrical pin 37 that projects through the movable plate 31 in its central opening 38 and is received in a pin seat surface 40 formed on the bottom wall 27 protrudes. . Further protruding from the same surface is an annular protrusion 41 intended to be placed on the movable plate 31 in order to push the movable plate 31 and keep it next to the bottom wall 27.

  A second cam shape is formed in the bottom wall by a suitable groove 50 into which the guide pin 39 of the movable plate 31 is inserted.

  Therefore, the work imposed on this cam shape is to move the movable plate 31 and then move the coupling member 21 and the terminal end 9 of the second catheter to engage the first end 3 of the first catheter 2, Or it can be separated from it.

  However, the movable plate 31 can follow a complicated path, which is a control device with a first cam shape that operates as the original cam of the movable plate 31 representing the cam follower, and is substantially defeated. It is also a control device with a modal dynamic system, i.e. a second cam shape that acts as a guide for realizing two or more guidance.

  In this connection, the movable plate 31 not only controls the coupling member 21 but also comprises cap capturing means and cap releasing means.

  The capturing means and the releasing means are substantially arranged on both sides of the coupling member 21 and consist of a cap seat surface formed in or integrally with the movable plate 31, as will be described in more detail below. These are to be described and are integrally formed on one side of the movable plate 31. Thereby, the movable plate 31 moves the capturing means, the coupling member, and the releasing means to a position corresponding to the second coupling port 26 of the second case 20, that is, to the position of the first end 3 of the first catheter 2. Can be rotated. Furthermore, it can be repositioned towards and away from the end 3 to actuate the capture means, the coupling member and the release means, respectively.

  In this embodiment, the cap 4 is made of plastic such as rubber, for example, and is a recess surrounded by an edge 42 that receives the end 3 of the first catheter 2 and elastically engages the end 3 to seal it. Have However, it should be noted that the catheter remains closed by the closure means 10.

  The cap 4 has a gripping projection 43 provided with a peripheral edge elastic flap 44 on the opposite side. Thereby, the capture means comprises a first cap seat surface 45 that is substantially cup-shaped and into which the gripping projection 43 is inserted. The gripping protrusion is fitted into the seat surface 45 so that the elastic flap 44 is in elastic contact with the inner surface of the first cap seat surface 45 and meshes geometrically.

  To capture the cap, the seat surface 45 need only be moved in the direction coaxial with the cap 4 toward the first end 3 until the gripping projection 43 is inserted into the cap seat surface 45. The first cap seat surface 45 is then pulled in the opposite direction until the cap 4 is disengaged from the end 3 of the catheter 2.

  Optionally, the first cap seating surface can have peripheral teeth 46 that irreversibly capture the cap 4 suitable for fitting the elastic flap 44 and the cap body within the frame.

  The release means is approximately equal to the capture means, which has a second cap seat surface 47 that receives another cap identical to that previously described.

  The second cap seat surface 47 maintains the respective caps 4 in their predetermined positions without contact between the elastic flap 44 and the inner surface as described with respect to the first cap seat surface 45. For this purpose, the second cap seat surface 47 has a slightly larger diameter than the first seat surface and / or a smoothed and / or non-adhesive inner surface for easily pulling out the gripping projections 43. Have In particular, such a seating surface need only lack the peripheral teeth 46 described with respect to the first seating surface 45. Therefore, it is a sufficient condition that the friction in the step of pulling out the cap 4 is smaller than the friction maintaining the cap 4 on its respective seating surface.

  In order to release the cap, it is only necessary to move the second seat surface 47 in a direction coaxial with the first end 3 until it is inserted into the recess of the cap 4. The second cap seat surface 47 is then pulled in the opposite direction to remove the cap 4 therefrom.

  With respect to the operation of this device, the pivot plate 32 can be rotated, for example in a counterclockwise direction, by means of checking (not shown) in order to carry out a capture, engagement, separation, release sequence. In this method, once the knob 33 is pivoted accordingly, the device 1, that is, a part of the device corresponding to the second case 20 is reused while the used cap 4 is held inside. I can't do that. Thus, the device 1 can be categorized as a disposable and easily disposable device.

  The device 1 already includes the flexible portion 8 in the second case 20 with the end portion 9 connected to the coupling member 21. This functions in this embodiment to connect the above portion of the second catheter to the first catheter 2 which is a CVC catheter for illustrative purposes.

  A single tubular member realized in this way lacks robustness.

  This tubular member already comprises a first case 5 and a coupling end 3 having an enlarged diameter and closed by a cap 4 and compressed by the closing means described above.

  The first case 5 and the second case 20 are coupled (FIG. 4), and the respective coupling ports are coupled to form a closed and airtight sealed container that already accommodates the catheter ends 3, 9 therein. It is possible to manipulate this by adjusting the knob 33. At the connecting portion between the second case 20 and the case 5, the cap 4 is captured by its intended seating surface (FIGS. 4A and 5).

  The knob 33 is then pivoted from its starting position along the first angle to the first position. This position of the knob 33 and the subsequent operating position are indicated by suitable markings on the outside of the second case 20, and a snap system is interposed between the front wall 28 of the second case 20 and the pivot plate 32. Can be formed.

  The seat surface 45 is pulled in the opposite direction while the cap 4 moves away from the cap 4 (FIG. 6), and the end 3 of the catheter 2 is exposed, but this is closed by the closing means of the first case 5. Yes.

When the knob 33 continues to pivot, the movable plate 31 is moved by the cam shape on the pivot plate 32 and the bottom wall 27 of the second case 20, and the coupling member 21 is first arranged in front of the coupling port 26. (FIG. 7A), and then the working edge 25 of the coupling member 21 pushes the working end 16 of the meshing clutch so as to keep the closing teeth pressing the end 3 of the first catheter 2 away from each other , Pushed out until the coupling edge 23 is inserted into the end of the catheter 2.

  In this way, fluid communication between the first catheter and the second catheter is instantaneously performed (FIG. 7B).

After completing the step in which the coupling is performed, the knob 33 is pivoted while maintaining the coupling member 21 away from the end 3 of the catheter 2. Therefore, the working edge 25 is not actuated against the meshing clutch 14 and the teeth 15 press the catheter 2 again. As a result, even if the coupling member 21 and the catheter 2 are separated, no fluid leaks from the first catheter 2. (Fig. 8)
By further pivoting the knob 33, the movable plate 31 rotates, and the coupling member 21 can then be pressed against the surface of the fixed shutter (not shown) inside the peripheral wall 29 of the second case 20. This also closes the second catheter.

  By this rotation, the release means, that is, the second cap seat surface 47 and its cap are arranged in front of the coupling port 26 of the second case 20. By further pivoting the knob 33, the cap seat surface 47 is pushed forward until the cap 4 is fitted to the end 3 of the first catheter 2 (FIG. 9). By pivoting the knob 33 again, the seat surface 47 is pulled in the opposite direction while the cap 4 closes the first catheter.

  At this stage, it is possible to separate the first case 5 and the second case 20 while keeping the first catheter 2 and the first case 5 in the same state as before the device 1 is used. The case 20 is discarded and can be replaced with another kit for the next use.

  The permission for the separation of the first case 5 and the second case 20 is to ensure that the knob 33 is fully engaged, just to avoid the end 3 of the first catheter 2 being exposed and detached due to the timing of separation being too early. This is done mechanically by a stop means (not shown) that prevents the case from separating until it is pivoted.

  However, it should be noted that even if the timing of separation is too early, the closure means 10 is immediately reactivated and the first catheter 2 is closed anyway.

  Thus, in the medical field, this device is disposable and easy to dispose of, the first catheter 2 with its respective first case 5 and a set of second catheters with its respective second case 20; It should be understood that they are sold as a single kit with

  In accordance with the same principle, the second case further accommodates two parts of different catheters, or two coaxial catheters, corresponding two coupling members, cap capture, engagement with the first catheter and Separation, possibly release and recapture of the intermediate cap (the latter is a completely optional step), engagement and separation with the second catheter, and most reliable release of another cap, followed by 2 It is also possible to provide a coupling device provided with a special internal drive allowing the separation of the two cases.

  For the coupling devices disclosed above, one of ordinary skill in the art can adopt several additional modifications and variations to accommodate other and uncertain requirements, anyway. They are all within the protection scope of the present invention as defined by the appended claims.

Claims (13)

A coupling device (1) connecting the two ends (3, 9) of the first tubular member and the second tubular member of the catheter, the coupling device (1) comprising:
- a first case housing the first end of the first tubular member having a closure means (10) (2) (3) (5),
- the second is accommodated in the flexible distal portion (8) in the tubular member, engaging a second end (9) retracted position of the second tubular member to the first end portion (3) A second case (20) comprising means for moving to a mating position and vice versa;
- e Bei and means defining a reversibly connected one sealing environment the first case (5) and the second casing (20) in the connection port,
The second case (20) has a box-like flat shape covered with a bottom wall (27), a front wall (28) and a peripheral wall (29), and is movable on the bottom wall (27). (31) comprises a pivot plate (32) on the movable plate (31),
A knob (33) protrudes outward from the front wall (28) from the pivot plate (32), and a guide pin (39) constituting two cam devices extends vertically from the movable plate (31). Extending, the upper end of the guide pin (39) is inserted into a rib (36) of the pivot plate (32) forming a first cam shape, and the lower end of the guide pin (39) is a second cam shape. The movement of the movable plate (31) is determined by the rotation of the pivot plate (32) by the knob (33), and is inserted into the groove (50) of the bottom wall (27) forming
The movable plate (31) is provided with a movable coupling member (21), and the second end (9) is coupled to the movable coupling member (21) in the second case (20), and the movable plate (31) is movable. The movement of the plate (31) moves the second end (9) from the retracted position to the position engaged with the first end (3) and vice versa, and the second end ( 9) A coupling device (9) in which the closing means (10) is automatically and mechanically activated and deactivated by the engagement and disengagement of 9) and the first end (3) is opened and closed. 1) The coupling device (1) according to claim 1, wherein the first case (5) has a substantially cylindrical shape and is coaxial with the first tubular member (2) of the catheter passing longitudinally through the case. ). The closure means comprises a plier-shaped device (18) having one or a set of meshing clutches (14) that compresses the first terminal end (3) of the first tubular member (2); The coupling device (1) according to claim 1 or 2. The coupling device (1) according to claim 3, wherein each meshing clutch (14) has teeth (15) for compressing and then closing the end (3) of the first tubular member (2). The meshing clutch (14) is composed of an elastic spring plate, and is bent by applying pressure in the longitudinal direction to the end portion thereof, thereby opening the end portion (3) of the first tubular member (2). The coupling device (1) according to claim 3 or 4, which can be made. The closing means is fitted to the first tubular member (2) at each of the terminal portions (3), and exposes a region where the first tubular member (2) faces in the vicinity of the terminal portion (3). A lock (11) having a pipe (11) with two opposing notches (12) to be left in place, the device (18) in the shape of the pliers being fitted and plugged into the pipe (11) The coupling device (1) according to claim 4, comprising a fixing ring (13), wherein the teeth (15) are inserted into respective notches (12) of the pipe (11). The coupling device (1) according to any of the preceding claims, wherein the movable coupling member (21) has an actuation extension (24) with an actuation edge (25). The coupling device (1) according to claim 7 , wherein the working edge (25) is formed to contact and push the working end (16) of the meshing clutch (14). Said movable plate (31) comprises means for releasing the cap means and / or tubular member to capture the cap of the tubular member, the coupling device according to any one of claims 1 to 8 (1). The capturing means and the releasing means are substantially constituted by cap seat surfaces (45, 47) disposed on both sides of the coupling member (21) and formed in or integrally with the movable plate (31). The coupling device (1) according to claim 9 , wherein: 10. A coupling device (1) according to claim 9 , wherein the capturing means comprises a cap seat surface (45) with peripheral teeth (46) for reversibly capturing the cap (4). The coupling device (1) according to claim 1, comprising stop means for permitting separation of the first case (5) and the second case (20). 13. A coupling device according to any of claims 1 to 12 , comprising a first catheter with the first case (5), and a set of second catheters with a second case (20). A disposable and easy-to-disposal kit.

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